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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

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BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE Back to Search Results
Model Number M00553560
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/01/2018
Event Type  Death  
Manufacturer Narrative
Date of event: approximated based on the month and year the first procedures were performed.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Report source: literature source: boxhoorn, l., verdonk, r., besselink, m., boermeester, m., bollen, t., bouwense, s., cappendijk, v., curvers, w., dejong, c., van dijk, s., van dullemen, h., van eijck, c., van geenen, e., hadithi, m., hazen, w., honkoop, p., van hooft, j., jacobs, m., kievits, j., kop, m., kouw, e., kuiken, s., ledeboer, m., nieuwenhuijs, v., perk, l., poley, jw., quispel, r., de ridder, r., van santvoort, h., sperna weiland, c., stommel, m., timmerhuis, h., witteman, b., umans, d., venneman, n., vleggaar, f., van wanrooij, r., bruno, m., fockens, p., voermans, r.The dutch pancreatitis study group.Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis.Boxhoorn l, et al.Gut 2023: 72:66-72.Doi: 10.1136/gutjnl-2021-325632.Impact code f02 captures the reportable event of death.
 
Event Description
Boston scientific became aware of events through the article "comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis" by dr.Rogier p.Voermans, et al.The study compared clinical outcomes after endoscopic transluminal drainage with lumen-apposing metal stents (lams) and double pigtail plastic stents in patients with infected necrotising pancreatitis.According to the literature, 53 patients were to be included in the study performed between june 01, 2018 and march 04, 2020; however, 1 of the 53 patients did not underwent endoscopic transluminal drainage with lams because the necrotic collection could not be visualized by endoscopic ultrasound (eus).Twenty- five patients were implanted with a 15mm x10mm axios stent and electrocautery- enhanced delivery system while 27 patients were implanted with 20mm x10mm axios stent and electrocautery- enhanced delivery system.Study showed 11% mortality rate in lams group while 18% in the plastic stents-group.A total of six patients died post axios stent placement while 9 patients died post plastic stent placement.It is unknown whether the axios stent contributed or caused the patient's death.Note: no further information has been obtained despite good faith efforts.
 
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Brand Name
AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Type of Device
PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key16363391
MDR Text Key309404102
Report Number3005099803-2023-00666
Device Sequence Number1
Product Code PCU
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberM00553560
Device Catalogue Number5356
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2023
Initial Date FDA Received02/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Death;
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